Q2 2026 Recap: Gastroenterology News & Updates

The second quarter of 2026 brought significant momentum in gastroenterology, with regulatory milestones, promising late-stage clinical trial results, and continued innovation across inflammatory bowel disease and pediatric gastrointestinal care. From new US Food and Drug Administration (FDA) approvals to advances in ulcerative colitis therapeutics, the quarter reflected a rapidly evolving treatment landscape aimed at improving outcomes for patients with complex GI diseases.

Among the quarter's key regulatory developments were the FDA acceptance of a new drug application for a next-generation hydrocortisone acetate suppository for ulcerative colitis of the rectum, the submission of a supplemental application for subcutaneous induction with risankizumab-rzaa in Crohn's disease, and approvals for single-dose famotidine injection and an expanded pediatric indication for linaclotide in functional constipation.

The inflammatory bowel disease pipeline also continued to advance, with positive clinical data supporting several investigational therapies. Phase 2 results for SPY001 reinforced the promise of anti-α4β7 targeting in ulcerative colitis, while phase 3 studies demonstrated encouraging efficacy for both tulisokibart, the first anti-TL1A therapy to meet phase 3 endpoints in ulcerative colitis, and obefazimod in patients with refractory disease.

In this Q2 gastroenterology review, the editorial team of HCPLive Gastroenterology recaps the quarter's most important regulatory updates, clinical trial milestones, and therapeutic advances that are shaping the future of gastrointestinal care.

SPY001, An Anti-α4β7, Shows Promise in Phase 2 SKYLINE Trial for Ulcerative Colitis

On April 13, 2026, Spyre Therapeutics announced positive 12-week induction data from Part A of the phase 2 SKYLINE trial of SPY001, a potential best-in-class anti-α4β7 being investigated for the treatment of moderate-to-severely active ulcerative colitis. The Company additionally announced that recruitment for Part A of SKYLINE is now closed and enrollment is open for Part B, which includes 3 monotherapy cohorts (SPY001, SPY002, and SPY003) and 3 combination cohorts (SPY120, SPY130, and SPY230) into which participants may be randomized versus a shared placebo.

FDA Accepts NDA For Next-Generation Hydrocortisone Acetate in Ulcerative Colitis of the Rectum

On April 21, 2026, the FDA accepted Cristcot’s New Drug Application (NDA) under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act for its next-generation hydrocortisone acetate (ngHCA) 90-milligram suppository administered using the Company’s patented, FDA-approved Sephure® suppository applicator for the treatment of patients with ulcerative colitis of the rectum. The NDA is supported by positive results from the Company’s phase 3 pivotal trial, which achieved its primary endpoint of clinical remission based on the Modified Mayo Score of 0-2 at Day 29.

With the acceptance, the FDA has set a PDUFA target date in October 2026. If approved, ngHCA would be the first and only FDA-approved hydrocortisone acetate (HCA) suppository.

Risankizumab (Skyrizi) SC Induction Application Submitted to FDA for Crohn's Disease

On April 27, 2026, AbbVie submitted a regulatory application to the FDA seeking approval for risankizumab-rzaa (Skyrizi) subcutaneous (SC) induction for adults with moderately to severely active Crohn's disease. The supplemental application is supported by positive data from the phase 3 AFFIRM study. If approved, risankizumab SC induction would offer an alternative to the currently approved intravenous (IV) induction regimen.

FDA Approves Famotidine Injection USP Single-Dose Vials

On May 13, 2026, the FDA approved Lupin Pharmaceuticals’ Abbreviated New Drug Applications for Famotidine Injection USP, 20 mg/2 mL (10 mg/mL), Single-Dose Vials, bioequivalent to the reference listed drug (RLD), Pepcid Injection, 10 mg/mL of Merck Sharp & Dohme Corp. Famotidine is a histamine-2 (H2) receptor antagonist that reduces gastric acid secretion and is used to treat gastrointestinal conditions associated with excess acid production.

FDA Approves Linaclotide (Linzess) for Functional Constipation in Patients 2 Years And Older

On May 27, 2026, the FDA approved Ironwood Pharmaceuticals’ linaclotide (Linzess) for pediatric patients ≥ 2 years of age with functional constipation (FC), expanding its previous approval for patients ≥ 6 years of age with FC.With this decision, linaclotide is now available for children ages 2-5 years with FC and remains the only FDA-approved prescription therapy for pediatric FC.

Related: FDA Expansion of Linaclotide for Children 2-5 Years With Functional Constipation

Tulisokibart Meets Phase 3 Endpoints in Ulcerative Colitis, First for Anti-TL1A

On June 22, 2026, Merck announced positive topline results from the phase 3 ATLAS-UC induction-only study (Study 2) evaluating tulisokibart (MK-7240), an investigational humanized monoclonal antibody targeting tumor necrosis factor-like cytokine 1A (TL1A), in patients with moderately to severely active ulcerative colitis. The study successfully met its primary endpoint of clinical remission according to the Modified Mayo Score at week 12 as well as key secondary endpoints, with no new safety concerns identified.

Obefazimod Delivers Week 44 Remission in Refractory UC Patients

On June 29, 2026, Abivax SA announced topline results from ABTECT Maintenance Part 2, the supplemental portion of its phase 3 ulcerative colitis maintenance program evaluating obefazimod, an investigational oral miR-124 enhancer, in adults with moderately to severely active ulcerative colitis. Results showed obefazimod delivered meaningful clinical benefit in a highly refractory ulcerative colitis population, with 37.2% of induction non-responders achieving clinical remission and 34.5% achieving endoscopic remission at week 44 following continued 50 mg treatment.